Overview:

Responsibilities:

• Up to 25% of time spent in Statistics, the remaining time spent on Management and Leadership tasks.
• Collaborate with PhD statisticians/epidemiologists, Statistical Research Associates (SRAs), laboratory scientists, laboratory data managers, and other subject-matter experts to provide statistical support for clinical studies and research projects or laboratory data and analyses including statistical considerations and planning(power and sample size calculations), randomization lists, consultation, study data analyses, and written summaries and tables of results for use in study reports - for example, Data and Safety Monitoring Boards or other interim review meetings, scientific abstracts and manuscripts, and/or tables in support of a Clinical Study Report for submission.
• Contribute to and review study documents including protocol drafts, statistical analysis plans, case report forms, and other documents as required.
• Collaborate with data management and operations in the development of quality assurance procedures for on-going data collection, cleaning and analysis - such as establishing edit checks, or HIV endpoint verification.
• Participate and lead in verification of standard reports prepared by programmers or other team members.
• Apply and adhere to CDISC data standards and guidelines where required in the production of analysis datasets and reports; assist in the production of supporting CDISC documentation for submissions (Define.xml, Reviewer’s Guides).
• Generate written summaries for use in customized statistical lab reports.
• Participate in and lead protocol team conference calls and meetings, organizational meetings, interim data review meetings, scientific meetings, regional meetings and internal team meetings as required.
• Represent SCHARP and the data analytics unit at professional meetings.
• Perform other responsibilities as required.

• Provide leadership and management to the network team of SRAs.
• Developand maintain staff morale, engagement and professional growth in pursuit of Irresistible Organization.
• Supervise and manage SRAs.
• Conduct performance reviews of direct reports.
• Maintain functional understanding of standard policies and procedures and complete required training in a timely manner; Contribute to the development and maintenance of standard procedures and related quality documents.
• Assign and monitor unit deliverables and related resources and timelines including communicating issues regarding conflicts and/or resource limitations to Director and study leadership.
• Provide input into long term resource planning.
• Lead interview and hiring process for the network team.
• Ensure quality and adherence to SOPs/WIs in the work and operations of direct reports and other team members. Oversee timely completion of QA documentation and training within team.

• Emphasis is primarily operational.
• Develop and maintain strategic vision for network team.
• Proactively communicate ideas and concerns to upper management.
• Develop and implement team process and quality improvement initiatives.
• Evaluate new statistical software packages.
• Lead and contribute to departmental efforts to standardize work practices and develop standard operating procedures to improve quality and efficiency in conformance with GCP, GCDMP and ICH guidelines, and that meet regulatory submission requirements and CDISC standards, such as writing and training on SOPs and work instructions.
• Develop, lead and participate in workshops, committees, initiatives and projects to support DAU and SCHARP goals.
• Establish goals and timelines for projects.
• Foster and promote the long-term development of the Data Analytics Unit.
• Participate in management team meetings.
• Provide training and mentoring support and career development opportunities to team.

Qualifications:

• MS or PhD degree in Statistics or Biostatistics or related field with demonstrated work experience.
• A minimum of 5 years of relatedwork experience is required.
• High-level proficiency with SAS or R (as required by specific team/project).
• Demonstrated functional knowledge of general statistical practice within clinical trials and demonstrated specialized knowledge of statistical practice within network specialization.
• Thorough understanding of statistical programming process and best practices.
• Minimum of 2 years of experience in a senior, lead or management role.
• Minimum of 2 years of experience statistical project management.
• Able to lead and advise on network-specific statistical tasks.
• Strong oral and written communication skills.
• Strong organizational and multi-tasking skills.
• Thorough understanding of network needs and objectives.
• Thorough understanding of GCP and regulatory requirements.
• Proven track record of collaboration with internal and external partners.
• Demonstrated experience in staff supervision and management.

• 7+ years of related work experience.
• 4+ years of experience in a senior, lead or management role.
• 4+ years of experience in statistical project management.
• Experience in drafting and maintaining controlled documents.
• VISC-specific preferences:
  • Experience with laboratory assay data.
  • Experience with R-markdown.
  • Experience with Git, GitHub, or other version control software.

Fred Hutchinson Cancer Center offers employees a comprehensive benefits package designed to enhance health, well-being, and financial security. Benefits include medical/vision, dental, flexible spending accounts, life, disability, retirement, family life support, employee assistance program, onsite health clinic, tuition reimbursement, paid vacation (12-22 days per year), paid sick leave (12-25 days per year), paid holidays (13 days per year), paid parental leave (up to 4 weeks), and partially paid sabbatical leave (up to 6 months).

Our Commitment to Diversity: We are proud to be an Equal Employment Opportunity (EEO) and Vietnam Era Veterans Readjustment Assistance Act (VEVRAA) Employer. We are committed to cultivating a workplace in which diverse perspectives and experiences are welcomed and respected. We do not discriminate on the basis of race, color, religion, creed, ancestry, national origin, sex, age, disability (physical or mental), marital or veteran status, genetic information, sexual orientation, gender identity, political ideology, or membership in any other legally protected class. We are an Affirmative Action employer. We encourage individuals with diverse backgrounds to apply and desire priority referrals of protected veterans. If due to a disability you need assistance/and or a reasonable accommodation during the application or recruiting process, please send a request to our Employee Services Center at hrops@fredhutch.org or by calling 206-667-4700.